CTIS Regulatory Technician: Submissions & Data Management

Fundacio Institu De Recerca En Energia De Catalunya; Barcelona; On-site; EUR 32,000 - 46,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Flexible country-specific benefits

Job summary

ICON is seeking a Regulatory Technician to join our team in Barcelona to support CTIS submissions and document management within Clinical Trials Information System. You will assemble and dispatch documents, coordinate resources for submissions, and ensure timely updates to stakeholders.

Ideal candidates have advanced English and 1–2 years of clinical research experience, with the ability to work independently.

Qualifications

• Mandatory advanced English (speak, read, write).
• 1–2 years relevant experience within clinical research or knowledge of clinical terminology and documentation.
• Ability to work independently.
• Experience with regulatory submissions and CTIS is a differential but not mandatory.

Responsibilities

• Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve
• Actively maintain applicable study-level account access for assigned projects for CTIS to maintain compliance and confidentiality
• Collaborate with key stakeholders to manage and perform data entry and document upload
• Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up
• Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS
• Perform Quality Control review in accordance with applicable process
• Maintain agreed timelines
• Ensure project-specific training is completed on time, as applicable

Skills

Advanced English

Independent worker

Regulatory submissions

Tools

CTIS

Job description

ICON is seeking a Regulatory Technician to join our team in Barcelona to support CTIS submissions and document management within Clinical Trials Information System. You will assemble and dispatch documents, coordinate resources for submissions, and ensure timely updates to stakeholders.

Ideal candidates have advanced English and 1–2 years of clinical research experience, with the ability to work independently.